Mexico – Mexican regulators set aggressive new deadlines for medical device equivalency route approvals

The Mexican Ministry of Health has set new review timeframes of five business days for medical devices submitted according to equivalency routes established with US, Canadian and Japanese regulators in 2010 and 2012.

A new decree (link in Spanish) from the ministry reduces Mexican medical device market regulator COFEPRIS’s approval times for equivalency route submissions from 15 business days to five for qualifying devices and technologies that have previously obtained market authorizations from the US Food and Drug Administration, Health Canada or Japan’s Ministry of Health, Labour and Welfare (MHLW). Through the expedited review program, COFEPRIS has aimed to provide manufacturers of qualifying devices faster access to the Mexican market with fewer registration requirements…